Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294743
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-14
Brief Title:
Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea
Sponsor:
Taichung Armed Forces General Hospital
Organization:
Taichung Armed Forces General Hospital
Study Overview
Official Title:
The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this crossover study is to assessed the treatment efficacy of posterior tibia nerve neuroprolotherapy on dysmenorrhea The primary outcome is the improvement of Visual Analogue Scale The main question it aims to answer is
Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea
Participants will be randomly allocated into two groups Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen500mg for the subsequent 2 menstrual cycles Group02 will received oral acetaminophen500mg in initial 2 menstrual cycles followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles
Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea
Participants will be randomly allocated into two groups Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen500mg for the subsequent 2 menstrual cycles Group02 will received oral acetaminophen500mg in initial 2 menstrual cycles followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles
Detailed Description:
This trial is a crossover study involving the enrollment of 60 women aged 20-50 who experience normal menstrual cycles accompanied by menstrual pain These participants will be randomly allocated into two distinct groups In Group-1 posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles followed by oral acetaminophen 500mg for the subsequent two menstrual cycles Conversely in Group-2 oral acetaminophen 500mg will be given during the initial two menstrual cycles followed by a transition to posterior tibial nerve neuroprolotherapy for the last two menstrual cycles The primary outcome measure for this trial is the improvement in the Visual Analog Scale VAS Secondary outcomes include an assessment of changes in quality of life before and after treatment as evaluated using the SF-36 questionnaire Furthermore pulse diagnosis instruments will be employed to analyze alterations in meridian energy before and after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None